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FDA 510(k)

CORE-SPORT

K-Number: K220081 · 2022-09-28

ApplicantIncore Co., Ltd.
Decision Date2022-09-28
Product CodeOTJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CORE-SPORT is a medical device manufactured by Incore Co., Ltd.. It received FDA 510(k) clearance on 2022-09-28 under approval number K220081. The device is classified under product code OTJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORE-SPORT?

CORE-SPORT is a medical device that received FDA 510(k) clearance on 2022-09-28. It is manufactured by Incore Co., Ltd.. The 510(k) number is K220081.

When was CORE-SPORT approved by the FDA?

CORE-SPORT received FDA 510(k) clearance on 2022-09-28, under approval number K220081.

What company makes CORE-SPORT?

CORE-SPORT is manufactured by Incore Co., Ltd..

What is the FDA product code for CORE-SPORT?

The FDA product code for CORE-SPORT is OTJ.

Other Devices by Incore Co., Ltd.

K221054CORE-INJECTOR K220846CORE-SNARE K213338CORE-CLIP K211148CORE-Trocar K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)

Related Devices (Code: OTJ)

K160797FMX314 Surgical PlatformFortimedix Surgical B.V. K152598Endo KeeperNelis K202688AFS Medical Sterile Single-Use Access Port SystemAfs Medical Co. , Ltd. K232062Uni-portDalim Medical Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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